Registration Dossier
Registration Dossier
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EC number: 203-063-4 | CAS number: 102-87-4
Endpoint summary
Administrative data
Description of key information
Additional information
Short-term toxicity to fish:
One study similar to ISO 7346 from the literature is available. The study performed with Zebrafish (Danio rerio) is considered to be reliable with restrictions since it is not performed under GLP and no analytical monitoring was performed. The LC50 in zebrafish is reported to be >3.2 mg/l
Long-term toxicity to fish:
Long-term toxicity to fish was waived. According to REACH Annex IX section 9.1 column 2, "long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment ... indicates the need to investigate further the effects on aquatic organisms." According to COMMISSION REGULATION (EC) No 134/2009 amending Annex XI of Regulation (EC) No 1907/2006 (REACH legal text) exposure-based waiving is possible provided "that it is demonstrated and documented that exposure in all scenarios is well below an appropriate derived no-effect level (DNEL) or predicted no effect concentration (PNEC) derived under specific conditions." Based on the outcome of the risk assessment, this test is not needed. The risk assessment for the substance indicates that no further chronic testing is necessary.
Short-term toxicity to aquatic invertebrates:
Two studies are available determining the toxicity to Daphnia magna. One study is a new OECD 202 study with GLP and considered to be the key study. The EC50 is determined to be 55.7 mg/L. The other study is an old study from literature for which it is unknow if it was performed according an offical guideline and which is considered to be less reliable. No analytic was performed and no information on nominal and tested concentration is given. The EC50 for 48h was determined to be 0.143 mg/l
long-term toxicity to aquatic invertebrates
A new OECD 211 study in Daphnia magna is available. After 21d exposure the NOEC is determined to be 12.35 mg/L. All criteria were met.
Toxicity to aquatic algae and cyanobacteria:
In a 72 hour acute toxicity study, the cultures of Scenedesmus subspicatus were exposed to the test item under static conditions in accordance with the OECD guideline 201. The ErC50 was found to be 17 mg/L. After a re- evaluation of the test study additionally an EC10: of 0.226 mg/l could be determined.
Toxicity to microorganisms:
A valid OECD 209 test with activated sludge of a domestic STP is available. After 3 h exposure time the EC10 and EC50 were determined to be >1000 mg/L.
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